Comparison of Two Multidisciplinary Rehabilitation Interventions in Patients With Chronic Low Back Pain

NCT02884466 | Completed

• 1 other identifier: Sano 1
• Study Type: interventional
• Target: 165
• Locations: 0 countries
• Sites: N/A

Brief Summary

Introduction Chronic low back pain (CLBP) is a highly prevalent health condition, and the leading cause of years lived with disability. The high prevalence causes a substantial impact on patients, communities and health-care systems. There is a continuing challenge to offer evidence-based rehabilitation for patients with CLBP. There is a lack of studies on adequate follow-up approaches to maintain successful treatment. No earlier study has assessed if the positive treatment effects of a multidisciplinary rehabilitation intervention can be maintained with an intervention alternating between inpatient interventions and home-based activities. Aim To assess if a novel multidisciplinary rehabilitation intervention is more effective in maintaining successful treatment after 6 months, than a usual multidisciplinary rehabilitation intervention in patients with CLBP. The novel intervention is a 14-week program alternating between in total three weeks of inpatient intervention and home-based activities. This alternation allows the participants time and opportunity to adapt and transfer inpatient learning to activities and participation in their own environment in interaction with everyday life situations and surroundings. Usual care is a four-week inpatient intervention. It is hypothesized that the intervention will be superior to usual care. Method The study will be conducted at The Danish Rheumatism Associations' rehabilitation centre Sano Aarhus. 160 participants with CLBP will be randomly allocated to one of two groups. The novel intervention consists of: 1) a pre-admission day, 2) two weeks of home-based activities, 3) two-week inpatient period, 4) four weeks of home-based activities, 5) 1st two-days inpatient follow-up, 6) six weeks of home-based activities and 7) 2nd two-days inpatient follow-up. Usual care consists of a four-week inpatient intervention. The two groups will be compared according to disability, pain, pain self-efficacy, quality of life, depression and exercise capacity. Relevance The present study has emerged out of the fields where patients, clinicians and researchers intersect and is consequently highly clinically relevant. If positive treatment effects can be maintained or even improved in the long term, the results may serve as inspiration for the design of multidisciplinary rehabilitation interventions in clinical practice; this will be valuable for future patients with CLBP.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

• The Oswestry Disability Index

  28 months

Secondary Outcomes (6)

• Numerical Rating Scale

  28 months

• The Pain Self-Efficacy Questionnaire

  28 months

• EQ-5D

  28 months

• Major Depression Inventory

  28 months

• Aastrands cycle test

  28 months

Study Arms (2)

Intervention group

EXPERIMENTAL

The intervention group will receive a multidisciplinary rehabilitation intervention consisting of: 1) a pre-admission day, 2) two weeks of home-based activities, 3) two-week inpatient period, 4) four weeks of home-based activities, 5) 1st two-days inpatient follow-up, 6) six weeks of home-based activities and 7) 2nd two-days inpatient follow-up.

Behavioral: Multidisciplinary rehabilitation intervention

Usual care group

ACTIVE COMPARATOR

The usual care group will receive a four-week inpatient multidisciplinary rehabilitation intervention.

Behavioral: Multidisciplinary rehabilitation intervention

Interventions

Multidisciplinary rehabilitation intervention BEHAVIORAL

Both groups will receive examination and medicine adjustment from a rheumatologist, and treatment from physiotherapist, occupational therapist and nursing staff, respectively. The multidisciplinary rehabilitation intervention in both groups will be based on the biopsychosocial model of illness. The inpatient stays of 8-10 hours per day will consist of 1) group tuition, 2) group and individual treatment and 3) unassisted training sessions.

Intervention group; Usual care group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• low back pain for more than 12 months with or without sciatica and/or with or without generalized pain identified by ICD-10 codes
• Oswestry Disability score \> 20.

You may not qualify if:

• a rated physical status of \> 3 according to the American Society of Anesthesiologists Physical Status Classification System
• axial spondyloarthritis
• spinal fracture within the last 3 months
• severe osteoporosis
• active cancer
• active psychiatric pathology assessed by general practitioner before referral
• pregnancy
• low Danish language skills.

Sponsors & Collaborators

• Sano: lead

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MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Anne Mette Schmidt, MSc

  Sano

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2016
• First Posted: August 31, 2016
• Study Start: October 1, 2016
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: January 28, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share